WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) and MedImmune, the global biologics
research and development arm of AstraZeneca, announced today that they
have entered into a clinical study collaboration. The Phase I/II
oncology study will evaluate the efficacy and safety of MedImmune’s
investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in
combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1)
inhibitor, INCB24360.

Both MEDI4736 and INCB24360 are investigational compounds that are part
of a new class of cancer treatments known as immunotherapies, which use
the body's own immune system to help fight cancer. MEDI4736 blocks the
signals that help tumors avoid detection by the immune system,
countering the tumor’s immune-evading tactics, while INCB24360 enhances
the ability of immune cells to combat the tumor. Preclinical evidence
suggests that the combination of these two agents may lead to an
enhanced anti-tumor immune response.

Under the terms of the agreement, MedImmune and Incyte will collaborate
on a non-exclusive basis on the study, to evaluate the combination in
multiple solid tumors including metastatic melanoma, non-small cell lung
cancer, squamous cell carcinoma of the head and neck and pancreatic
cancer. The Phase I part of the trial is expected to establish a
recommended dose regimen of both MEDI4736 and INCB24360 and the Phase II
part of the study will assess the safety and efficacy of the
combination. Results from the study will be used to determine whether
further clinical development of this combination is warranted. The study
will be co-funded equally by Incyte and MedImmune and conducted by
Incyte.

Dr. Bahija Jallal, Executive Vice President, MedImmune, said:
“Immuno-oncology is one of the most exciting areas in our industry and
we are progressing our strong pipeline as rapidly as possible. Our
partnership with Incyte is further evidence of our belief that
combination therapies have the potential to be one of the most effective
ways of treating cancer.”

“Research collaborations that evaluate combinations of novel
immunotherapies across a broad range of indications have the potential
to accelerate our understanding of this rapidly evolving field, to
identify new areas of opportunity for immunotherapies, and to more
rapidly address the unmet needs of patients with a wide range of
cancers,” said Hervé Hoppenot, President and Chief Executive Officer of
Incyte. “For these reasons, we welcome the opportunity to work with
MedImmune to explore the potential of combining MEDI4736 with INCB24360.”

About INCB24360

INCB24360 is an orally bioavailable small molecule inhibitor of IDO1
that has nanomolar potency in both biochemical and cellular assays,
potent activity in enhancing T lymphocyte, dendritic cell and natural
killer cell responses in vitro, with a high degree of selectivity.
INCB24360 has been shown to be efficacious in mouse models of cancer as
a single agent and in combination with cytotoxic and immunotherapy
agents, and its ability to reduce tumor growth is dependent on a
functional immune system – consistent with its proposed mechanism of
action. A Phase I dose-escalation trial demonstrated that INCB24360
results in greater than 90 percent inhibition of IDO1 activity at
generally well-tolerated doses.

INCB24360 is currently in Phase I/II development for metastatic melanoma
in combination with ipilimumab (www.clinicaltrials.gov
Identifier: NCT01604889) and as monotherapy for ovarian cancer (www.clinicaltrials.gov
Identifier: NCT01685255). Incyte has also established a clinical
agreement with Merck to combine INCB24360 with Merck’s novel anti-PD-1
immunotherapy checkpoint inhibitor, MK-3475.

About MEDI4736

MEDI4736 is an investigational human monoclonal antibody directed
against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help
tumors avoid detection by the immune system. MEDI4736 blocks these
signals, countering the tumor’s immune-evading tactics. MEDI4736 is
being developed, alongside other immunotherapies (IMTs), to empower the
patient’s immune system and attack the cancer.

AstraZeneca and MedImmune have recently initiated other immuno-oncology
combination trials, including MEDI4736 with IRESSA and MEDI4736 with
tremelimumab. Other combination trials are planned to start imminently,
demonstrating the strength and rapid progression of the company’s
immuno-oncology portfolio.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary small molecule drugs, primarily for oncology. For additional
information on Incyte, please visit the Company's website at www.incyte.com.

About MedImmune

MedImmune is the worldwide biologics research and development arm of
AstraZeneca. MedImmune is pioneering innovative research and exploring
novel pathways across key therapeutic areas, including respiratory,
inflammation and autoimmunity; cardiovascular and metabolic disease;
oncology; neuroscience; and infection and vaccines. The MedImmune
headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three
global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation statements
with respect to the potential efficacy, safety and therapeutic value of,
and Incyte’s plans for, INCB24360, and the plans and expectations
regarding the Phase I/II study in the clinical study collaboration with
MedImmune, contain predictions and estimates and are forward-looking
statements within the meaning of the "safe harbor" provisions of the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on Incyte’s current expectations and subject to
risks and uncertainties that may cause actual results to differ
materially, including unanticipated developments in and risks related to
the efficacy or safety of INCB24360, the results of further research and
development, the high degree of risk and uncertainty associated with
drug development, clinical trials and regulatory approval processes,
other market or economic factors and technological advances, the ability
of Incyte to compete against parties with greater financial or other
resources, and other risks detailed from time to time in Incyte's
filings with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.
Incyte disclaims any intent or obligation to update these
forward-looking statements.